Brand of the Year: Crestor

Though 2008 was not a banner year for pharma, the industry can still pat itself on the back: It continued to extend control over HIV with three important new drugs, including Merck's Isentress; Treanda, brought to market by Cephalon, became the first advance against CLL in seven years; and Pfizer revamped an old pain drug as Lyrica for a newish condition, fibromyalgia. All three drugs showcased pharma's drive toward innovation in discovery, development, or marketing. For patients who benefited by them, each drug was no doubt the brand of the year. (See sidebars for more on each of these three finalists.)

The Crestor brand team, led by Lisa Nanfra, may be doing for C-Reactive Protein what they did for atherosclerosis. "It will be up to the regulatory and other guidelines bodies to make use of the JUPITER trial information in terms of clinical practice," Nanfra says. "But regardless, we are incredibly proud of the fact that we have been part of helping advance scientific knowledge."

For our third annual Brand of the Year, however, Pharm Exec is honoring AstraZeneca's Crestor (rosuvastatin)—a selection that struck some of our advisors as eccentric. After all, Crestor is not a medical breakthrough, first in class, or even new. Cynics asked if its recent success is anything more than a marketing marvel.

Crestor's sales are a marvel—and something of a mystery. Since generic simvastatin (Zocor) hit in 2006, it has wreaked havoc on the $34 billion cholesterol market, long a leading engine of the blockbuster economy. Copycats immediately crushed sales of Zocor with a 97 percent switch rate in the first 12 months, according to Datamonitor. Sales of Pfizer's Lipitor—the fattest pharma cash cow ever—plunged 20 percent from Q1 2005 to Q2 quarter 2008. Crestor, alone among branded statins, has made gains—big ones. According to the drugmaker, in 2005, the superstatin recorded $1.2 billion in global sales; in 2006, $2.1 billion; in 2007, $2.8 billion; and in 2008, an estimated $3.5 billion.

A print ad (left) and three images from a TV spot for Crestors atherosclerosis DTC campaign.

Crestor's improbable success derives from AZ's determined belief in the drug's value and its willingness to take big risks to demonstrate that value. Born amid a tempest, Crestor weathered the worst of the post-Vioxx storms to find safe harbor as the statin of choice for patients at highest risk for cardiovascular disease; in order to make the most of its major feature, high potency, AstraZeneca invested in an ambitious range of postmarketing trials. In 2007, the science earned Crestor the only indication among its class to treat atherosclerosis.

A giant Crestor trial called JUPITER was also responsible for what was arguably 2008's biggest medical news, supporting the use of statins to prevent heart attack and stroke in healthy people with normal LDL cholesterol but high levels of a C-Reactive Protein (CRP), a marker for inflammation. "The trial was originally conceived to see how important a factor inflammation is in cardiovascular disease," CEO David Brennan told The Wall Street Journal last March.

If, as expected, FDA approves Crestor to lower CRP, it will be "another plank in the bridge we have built for this product," Brennan said. It will also likely set in motion a paradigm shift in cardiovascular medicine, addressing the long-unmet medical need of the healthy—who suffer nearly half of all heart attacks and strokes.

Expanding the statin market to include testing and treatment for inflammation could send Crestor sales as high as $15 billion by 2016, when the patent expires. Such a scenario is unlikely to materialize unless AZ can win the daunting cost-effectiveness battle, but one thing is certain: As the other statins fade, Crestor's best days are still ahead.